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Concerta (Methylphenidate Hydrochloride) - Summary



CONCERTA® should be given cautiously to patients with a history of drug dependence or alcoholism. Chronic abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behavior. Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during withdrawal from abusive use since severe depression may occur. Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up.



CONCERTA® is a central nervous system (CNS) stimulant.

CONCERTA® is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents, and adults up to the age of 65 [see Clinical Studies].

A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; "on the go;" excessive talking; blurting answers; can't wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.

Special Diagnostic Considerations

Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use of medical and special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the patient and not solely on the presence of the required number of DSM-IV characteristics.

Need for Comprehensive Treatment Program

CONCERTA® is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social). Drug treatment may not be indicated for all patients with ADHD. Stimulants are not intended for use in patients who exhibit symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the patient's symptoms.

See all Concerta indications & dosage >>


Published Studies Related to Concerta (Methylphenidate)

The Effect of Methylphenidate on Fatigue in Advanced Cancer: An Aggregated N-of-1 Trial. [2015]
advanced cancer... CONCLUSION: MPH does not improve fatigue in the population of patients with

Drug-specific laterality effects on frontal lobe activation of atomoxetine and methylphenidate in attention deficit hyperactivity disorder boys during working memory. [2014]
CONCLUSIONS: The study shows both shared and drug-specific effects. ATX

Long-term (1 year) safety and efficacy of methylphenidate modified-release long-acting formulation (MPH-LA) in adults with attention-deficit hyperactivity disorder: a 26-week, flexible-dose, open-label extension to a 40-week, double-blind, randomised, placebo-controlled core study. [2014]
26-week, open-label extension phase of the same study (NCT01338818)... CONCLUSIONS: In adult patients with ADHD, use of MPH-LA up to 1 year continued to

Effect of extended-release dexmethylphenidate and mixed amphetamine salts on sleep: a double-blind, randomized, crossover study in youth with attention-deficit hyperactivity disorder. [2014]
measures of sleep... CONCLUSIONS: Higher stimulant doses were associated with reduced sleep duration

A randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of osmotic-controlled release oral delivery system methylphenidate HCl in adults with attention-deficit/hyperactivity disorder in Japan. [2014]
attention-deficit/hyperactivity disorder (ADHD)... CONCLUSIONS: OROS MPH in a dose range of 18-72 mg once daily was effective and

more studies >>

Clinical Trials Related to Concerta (Methylphenidate)

Safety and Efficacy of MTS Versus Concerta in Pediatric Patients (Aged 6-12 Years) With ADHD [Completed]
Study designed to evaluate the safety and efficacy of MTS compared to placebo with reference to CONCERTA in pediatric subjects diagnosed with ADHD.

A Study to Explore Plasma Levels of CONCERTA, Ritalin-SR and Novo-Methylphenidate ER-C in Healthy Volunteers [Completed]

A Drug Interaction Study of SPD503 and Concerta Administered Alone and In Combination in Normal Healthy Volunteers [Completed]
This is a drug-drug interaction study; the purpose of this study is to examine the pharmacokinetics (levels of drug in the blood) of SPD503 (guanfacine hydrochloride) and Concerta (methylphenidate HCl) when given alone, and in combination.

Methylphenidate Study in Breast or Gastrointestinal Cancer Patients [Terminated]
The goal of this clinical research study is to see if the drug OROS Methylphenidate HCl (Concerta) can help to control fatigue in patients with breast, gastrointestinal, lymphoma, myeloma or lung cancer who are going through chemotherapy or hormonal treatment or have completed chemotherapy or hormonal treatment in the last 12 months. The safety of this drug will also be studied. Another goal of the study is to see how certain cytokines change while patients undergo chemotherapy or hormonal treatment.

A Double-Blind Comparison of Concerta and Placebo in Adults With Attention Deficit Hyperactivity Disorder [Completed]
This is a double-blind, placebo-controlled study using daily doses of up to 1. 3 mg/kg/day of Concerta in the treatment of adults with the DSM-IV diagnosis of attention deficit hyperactivity disorder (ADHD) (childhood onset). We hypothesize ADHD symptomatology in adults with DSM-IV ADHD will be responsive to Concerta treatment and Concerta-associated response of ADHD symptomatology in adults will be sustained over time.

more trials >>

Reports of Suspected Concerta (Methylphenidate) Side Effects

Drug Ineffective (34)Suicidal Ideation (31)Overdose (27)Abnormal Behaviour (26)Decreased Appetite (25)Aggression (23)Psychotic Disorder (21)Drug Dose Omission (19)Dizziness (17)Growth Retardation (17)more >>


Based on a total of 14 ratings/reviews, Concerta has an overall score of 6.29. The effectiveness score is 7.43 and the side effect score is 6.86. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.

Concerta review by care giver of 13 year old female patient

Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Mild Side Effects
Treatment Info
Condition / reason:   ADD
Dosage & duration:   27 MG taken daily for the period of 5 YEARS
Other conditions:   N/A
Other drugs taken:   N/A
Reported Results
Benefits:   As an ADD child unable to process information propertly, the medication helped her get focused and understand better while in school. Her anxiety level was controlled and helped loose some weight. She was able to control better the outburst socially.
Side effects:   some slight headaches and lacking energy, complainingof being tired.
Comments:   Medication was prescribed while in second grade. Socially and academically it helped her quite significantly. In school she was in special classes and the medicationhas helped her get mainstreamed into regular classes. She is able to soialize a bit better along with therapy. Her level of anxiety is better making her behave a little more relaxed and controlling regular outbursts. It also helped her in her weight due to the anxiety control. Definately able to see the difference when not taking the medication. Difficult to be in school without it.


Concerta review by 35 year old male patient

Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Mild Side Effects
Treatment Info
Condition / reason:   ADHD
Dosage & duration:   27 mg taken once daily for the period of 3 months
Other conditions:   none
Other drugs taken:   none
Reported Results
Benefits:   I was able to concentrate and complete daily tasks. I didn't have to write notes to myself and constantly put them in various places so I would run into during the day.l
Side effects:   I get a bit irritable when the medication wears off for about 30 minutes. I also feel quite tired during this time.
Comments:   My primary care physician prescribe it after telling him my problems I've had my entire life in concentrating/completing tasks. I was also very forgetful but don't have any of these problems except on occasion when I have too many things going on.


Concerta review by 39 year old female patient

Overall rating:  
Effectiveness:   Ineffective
Side effects:   Severe Side Effects
Treatment Info
Condition / reason:   ADHD
Dosage & duration:   18 mg taken 1 a day for the period of 2 days
Other conditions:   Depression
Other drugs taken:   Lexapro, Lamactol , Clonzapam
Reported Results
Benefits:   None!
Side effects:   Felt like I was speeding out of my mind. I couldn't function, forgot to go to work on time, rectol bleeding, felt like I couldn't breathe, still rectol bleeding after not taking it for 2 days. Have slept alot since not taking it. This had horrible side effects for me from the start. I read the reviews and see I am a older person taking this drug, but I Don't see how anyone could normally function on this drug. I didn't know if I was coming or going and it also made me feel akward when driving. Dangerous drug!
Comments:   >>

See all Concerta reviews / ratings >>

Page last updated: 2015-08-10

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